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Mag 5 Pt Warming Formula

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Active ingredient
Menthol 5.6 g/112 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
March 25, 2025
Active ingredient
Menthol 5.6 g/112 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
March 25, 2025
Manufacturer
RENU LABORATORIES, LLC
Registration number
M017
NDC root
76348-511

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Drug Overview

MAG5 PT WARMING CREAM is a topical cream designed to provide temporary relief from minor aches and pains in muscles and joints. It is often used in conjunction with deep muscle therapy treatments, helping to soothe discomfort and enhance your overall comfort during recovery or physical activity.

This cream works by applying heat to the affected area, which can help to relax muscles and improve blood flow, making it a supportive option for those experiencing muscle tension or joint pain.

Uses

If you're experiencing minor aches and pains in your muscles and joints, especially after deep muscle therapy treatments, this medication can provide temporary relief. It's designed to help ease discomfort, allowing you to feel more comfortable and get back to your daily activities. Always consult with a healthcare professional if you have any questions about your symptoms or treatment options.

Dosage and Administration

If you are 12 years old or older, you can apply this medication to the affected area up to 10 times a day, or as your physical or occupational therapist advises. Make sure to follow their instructions closely for the best results.

If you are caring for a child under 12, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional guidance when it comes to younger patients.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns regarding abuse, misuse, or dependence, you should stop using the medication and consult your doctor if your condition worsens, if symptoms persist for more than 7 days, or if symptoms improve and then return within a few days. Your health and safety are paramount, so don't hesitate to seek medical advice if you have any concerns.

Side Effects

This product is intended for external use only. If your condition worsens, or if your symptoms last longer than 7 days, or if they improve and then return within a few days, you should stop using the product and consult a doctor. It's important to pay attention to these signs to ensure your health and safety.

Warnings and Precautions

This product is intended for external use only. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if your symptoms improve and then return within a few days. It's important to pay attention to how your body responds while using this product.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

Currently, there is no information available about the use of MAG 5 PT WARMING FORMULA during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert. If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider for personalized advice and to discuss any medications you may be considering. Your health and the health of your baby are the top priority, so always seek professional guidance when it comes to medication use during pregnancy.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

If your child is under 12 years old, it's important not to use this product without first consulting a doctor. For children aged 12 and older, you can apply the product to the affected area, but make sure to do so no more than 10 times a day, or follow the instructions given by your physical or occupational therapist. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs, ensuring that any medication is safe and effective for you. Always keep an open line of communication with your doctor about any changes in your health or any side effects you may experience.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is particularly true if your kidneys are not functioning as well as they should be. Regular monitoring of your renal function tests (which check how well your kidneys are working) is essential to ensure your safety and the effectiveness of your treatment.

If your creatinine clearance (a measure of kidney function) is less than 30 mL/min, you should consider using a lower dose of your medication. Always consult with your healthcare provider to determine the best approach for your specific situation.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's great to know that there are no reported drug interactions or laboratory test interactions with this medication. However, it's still very important to discuss all the medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication is key to managing your health effectively.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, up to 10 times a day, or as directed by your physical or occupational therapist if you are an adult or a child aged 12 years and older. If you are caring for a child under 12, do not use this medication without consulting a doctor first.

Currently, there is no additional information available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is MAG5 PT WARMING CREAM used for?

MAG5 PT WARMING CREAM is used for temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments.

Who can use MAG5 PT WARMING CREAM?

Adults and children 12 years of age and older can use it, applying to the affected area no more than 10 times a day. Children under 12 years should not use it without consulting a doctor.

What should I do if my condition worsens or symptoms persist?

You should stop using the cream and ask a doctor if your condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Are there any specific warnings for using this cream?

Yes, it is for external use only. If swallowed, seek medical help or contact a Poison Control Center immediately.

How should I store MAG5 PT WARMING CREAM?

Store the cream at room temperature, protect it from light, and do not freeze. Discard it after opening.

Is there any information regarding use during pregnancy or lactation?

There is no specific information provided regarding the use of MAG5 PT WARMING CREAM during pregnancy or lactation.

What should I know about using this cream if I have kidney problems?

If you have reduced renal function, dosage adjustments may be necessary, and renal function tests should be monitored regularly.

Packaging Info

Below are the non-prescription pack sizes of Mag 5 Pt Warming Formula (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mag 5 Pt Warming Formula.
Details

Drug Information (PDF)

This file contains official product information for Mag 5 Pt Warming Formula, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

MAG5 PT Warming Cream is presented in a multi-layered label format, ensuring clear identification and information dissemination. The product is packaged in a box labeled for the year 2025, indicating its intended use and branding. The design of the label and box reflects the product's purpose and enhances its visibility in a professional setting.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with deep muscle therapy treatments. It is intended for use in patients undergoing such therapeutic interventions to alleviate discomfort.

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area no more than 10 times per day, or as directed by a physical or occupational therapist.

In children under 12 years of age, the product should not be used without consulting a doctor.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Warnings and Precautions

For external use only. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring for these signs is essential to ensure patient safety and effective management of the condition being treated.

Side Effects

For external use only. Patients should stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no specific monitoring or dosage adjustments are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Mag 5 Pt Warming Formula (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mag 5 Pt Warming Formula.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this product without consulting a healthcare professional. For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 10 times a day, or as directed by a physical or occupational therapist.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of MAG 5 PT WARMING FORMULA during pregnancy, including safety concerns, dosage modifications, or any special precautions. Healthcare professionals should consider this lack of data when prescribing this product to pregnant patients or women of childbearing potential. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes in the absence of specific information.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. Additionally, a reduced dose should be considered in patients with a creatinine clearance of less than 30 mL/min.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Additionally, patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is important for healthcare providers to emphasize these points to ensure patient safety and effective management of their condition.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with specific guidelines for different age groups. Adults and children aged 12 years and older may apply the treatment to the affected area up to 10 times a day, or as directed by a physical or occupational therapist. For children under 12 years of age, the product should not be used without consulting a doctor.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Mag 5 Pt Warming Formula, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Mag 5 Pt Warming Formula, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.